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August 11, 2020

Roche announces mixed Phase III results of etrolizumab

Roche has reported mixed top-line data from the Phase III clinical study programme of etrolizumab in patients with moderately to severely active ulcerative colitis.

Roche has reported mixed top-line data from the Phase III clinical study programme of etrolizumab in patients with moderately to severely active ulcerative colitis.

Across two studies, the drug as a maintenance therapy did not meet the primary endpoints, with no significant difference in the proportion of subjects experiencing remission with subcutaneous etrolizumab compared to placebo.

The drug, however, met the primary endpoint in the HIBISCUS I induction trial involving patients who had no previous anti-tumour necrosis factor (anti-TNF) treatment.

But the HIBISCUS II induction study, which also enrolled participants without prior anti-TNF treatment, did not meet its primary goal.

The HICKORY trial, which recruited people with prior anti-TNF treatment, met the primary endpoint at induction but not at maintenance.

However, in the LAUREL maintenance study of patients without prior anti-TNF treatment, etrolizumab failed to meet the primary endpoint.

The safety profile of the drug was reported to be consistent with prior studies and no major safety issues have been observed in the four Phase III trials to date.

Roche chief medical officer and Global Product Development head Levi Garraway said: “We are disappointed with these results, because we know that people with ulcerative colitis need new treatment options. We are fully analysing these data to learn more about how we might address the needs of people with this devastating disease.

“These studies were part of the largest clinical trial programme ever undertaken in inflammatory bowel diseases, and we thank all the patients, investigators and healthcare professionals for their participation.”

Trial data, including secondary endpoints, are being further analysed.

The company is also studying etrolizumab as an potential induction and maintenance treatment in patients with moderately to severely active Crohn’s disease with and without prior anti-TNF treatment.

Last week, Roche reported that the combination of Tecentriq (atezolizumab) plus paclitaxel (chemotherapy) failed to meet the primary goal in the Phase III IMpassion131 trial for PD-L1-positive metastatic triple-negative breast cancer (TNBC).

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